Biologics Process Development Associate

Amgen SA; Thousand Oaks (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Associate – Biological and Structural Characterization to advance potency methods and product characterization. You will develop analytical assays for release and stability, prepare investigative reports, and analyze data to support regulatory submissions.

You will collaborate with product development and quality teams, ensuring thorough documentation and efficient transfer of methods.

Qualifications

• Bachelor’s degree or higher in a life-science field or equivalent.
• Experience with cell culture and quantitative analysis of proteins.
• Experience with cell-based bioassay development and transfer.
• Knowledge of signal transduction, gene expression, and receptor binding.
• Excellent documentation and detail orientation.

Responsibilities

• Implement analytical potency methods for release, stability, and characterization.
• Prepare technical reports for investigations and regulatory submissions.
• Generate and analyze data to support product development and regulatory filings.
• Contribute to analytical development teams with data interpretation and documentation.

Skills

Cell culture

Cell biology techniques

Bioassay development

Signal transduction

Gene expression

Receptor binding

Fluorescent probes

Documentation skills

Automated liquid handling

Client orientation

Communication skills

Education

Bachelor’s degree

Associate’s degree + 2 years operations experience

High school diploma / GED + 4 years operations experience

Job description

Amgen in Thousand Oaks, CA seeks a Process Development Associate – Biological and Structural Characterization to advance potency methods and product characterization. You will develop analytical assays for release and stability, prepare investigative reports, and analyze data to support regulatory submissions.

You will collaborate with product development and quality teams, ensuring thorough documentation and efficient transfer of methods.